Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The degree to which vigabatrin (Sabril) is safely tolerated by Tuberous Sclerosis patients.
Safety blood draws (AED levels, comprehensive panel, CBC with differential) Visual field tests, and ophthalmology exams Frequency and severity of adverse events reported by subjects throughout their involvement with the study
every 3 months throughout the study
Yes
John Pollard, MD
Principal Investigator
University of Pennsylvania
United States: Food and Drug Administration
811542
NCT01266291
August 2010
December 2013
Name | Location |
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University of Pennsylvania | Philadelphia, Pennsylvania 19104 |